Home / 510(k) Clearances / K141015

510(k) K141015

INTELLIVUE PATIENT MONITOR MX400, INTELLIVUE PATIENT MONITOR MX450, INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2014
Date Received
April 21, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

Other clearances by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN

  • K132320 — INTELLIVUE CL RESPIRATION POD (March 26, 2014)
  • K131872 — INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT MONITOR MX550 (October 17, 2013)
  • K131829 — INTELLIVUE PATIENT MONITOR (August 16, 2013)
  • K130849 — INTELLIVUE PATIENT MONITOR MX400; INTELLIVUE PATIENT MONITOR MX450 (June 14, 2013)
  • K120366 — INTELLIVUE PATIENT MONITOR (July 18, 2012)
  • K113441 — PHYSIOLOGICAL MONITOR, PATIENT MONITOR (March 22, 2012)
  • K111905 — INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP02 POD MODEL 865215, (October 4, 2011)
  • K110474 — PHILIPS INTELLIVUE TCG10 (September 30, 2011)
  • K111083 — PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50 (August 17, 2011)
  • K110622 — INTELLIVUE PATIENT MONITOR (March 31, 2011)

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  • K250757 — Radius VSM and Accessories (May 29, 2025)
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